Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general (...) attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants. (shrink)

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

Volume 20, Issue 5, June 2020, Page 18-20.

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces (...) a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable. (shrink)

Tryon has proposed the definition of a scientific explanation as an explanation that reduces uncertainty, and relates this to the reduction of statistical variance. Lamiell criticizes Tryon on several grounds, arguing that the reduction of criterion variance does not yield knowledge of the sort Tryon desires. This paper comments on Tryon's proposal, including his reply to Lamiell's criticisms. It is concluded that explanation as uncertainty reduction is a simple recapitulation of the Hempelian model of explanation at the theoretical level, and (...) an erroneous conception of statistical epistemology at the methodological level. 2012 APA, all rights reserved). (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected (...) outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type can be confused with expressionsof uncertainty of the belief type. Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process. (shrink)

Our aim in this entry is to articulate the state of the art in the moral psychology of personal identity. We begin by discussing the major philosophical theories of personal identity, including their shortcomings. We then turn to recent psychological work on personal identity and the self, investigations that often illuminate our person-related normative concerns. We conclude by discussing the implications of this psychological work for some contemporary philosophical theories and suggesting fruitful areas for future work on personal identity.

Many experimental philosophers are philosophers by training and professional affiliation, but some best work in experimental philosophy has been done by people who do not have advanced degrees in philosophy and do not teach in philosophy departments. This chapter explains that the experimental philosophy is the empirical investigation of philosophical intuitions, the factors that affect them, and the psychological and neurological mechanisms that underlie them. It explores what are philosophical intuitions, and why do experimental philosophers want to study them using (...) the methods of empirical science. The positive program in experimental philosophy shares the goal of the substantial part of traditional philosophy that is concerned with the analysis of important philosophical concepts. The negative program has implications for philosophical projects whose goal is conceptual analysis. There have been a number of responses to the challenge posed by experimental philosophy's negative program. The chapter also focuses on the expertise defense. (shrink)

The Twin Earth thought experiment invites us to consider a liquid that has all of the superficial properties associated with water (clear, potable, etc.) but has entirely different deeper causal properties (composed of “XYZ” rather than of H2O). Although this thought experiment was originally introduced to illuminate questions in the theory of reference, it has also played a crucial role in empirically informed debates within the philosophy of psychology about people’s ordinary natural kind concepts. Those debates have sought to accommodate (...) an apparent fact about ordinary people’s judgments: Intuitively, the Twin Earth liquid is not water. We present results from four experiments showing that people do not, in fact, have this intuition. Instead, people tend to have the intuition that there is a sense in which the liquid is not water but also a sense in which it is water. We explore the implications of this finding for debates about theories of natural kind concepts, arguing that it supports views positing two distinct criteria for membership in natural kind categories – one based on deeper causal properties, the other based on superficial, observable properties. (shrink)

Phineas Gage’s story is typically offered as a paradigm example supporting the view that part of what matters for personal identity is a certain magnitude of similarity between earlier and later individuals. Yet, reconsidering a slight variant of Phineas Gage’s story indicates that it is not just magnitude of similarity, but also the direction of change that affects personal identity judgments; in some cases, changes for the worse are more seen as identity-severing than changes for the better of comparable magnitude. (...) Ironically, thinking carefully about Phineas Gage’s story tells against the thesis it is typically taken to support. (shrink)

The Twin Earth thought experiment invites us to consider a liquid that has all of the superficial properties associated with water (clear, potable, etc.) but has entirely different deeper causal properties (composed of “XYZ” rather than of H2O). Debates about natural kind concepts have sought to accommodate an apparent fact about ordinary people's judgments: Intuitively, the Twin Earth liquid is not water. We present results showing that people do not have this intuition. Instead, people tend to judge that there is (...) a sense in which the liquid is not water but also a sense in which it is water. (shrink)

A classic debate concerns whether reasonableness should be understood statistically (e.g., reasonableness is what is common) or prescriptively (e.g., reasonableness is what is good). This Article elaborates and defends a third possibility. Reasonableness is a partly statistical and partly prescriptive “hybrid,” reflecting both statistical and prescriptive considerations. Experiments reveal that people apply reasonableness as a hybrid concept, and the Article argues that a hybrid account offers the best general theory of reasonableness. -/- First, the Article investigates how ordinary people judge (...) what is reasonable. Reasonableness sits at the core of countless legal standards, yet little work has investigated how ordinary people (i.e., potential jurors) actually make reasonableness judgments. Experiments reveal that judgments of reasonableness are systematically intermediate between judgments of the relevant average and ideal across numerous legal domains. For example, participants’ mean judgment of the legally reasonable number of weeks’ delay before a criminal trial (ten weeks) falls between the judged average (seventeen weeks) and ideal (seven weeks). So too for the reasonable num- ber of days to accept a contract offer, the reasonable rate of attorneys’ fees, the reasonable loan interest rate, and the reasonable annual number of loud events on a football field in a residential neighborhood. Judgment of reasonableness is better predicted by both statistical and prescriptive factors than by either factor alone. -/- This Article uses this experimental discovery to develop a normative view of reasonableness. It elaborates an account of reasonableness as a hybrid standard, arguing that this view offers the best general theory of reasonableness, one that applies correctly across multiple legal domains. Moreover, this hybrid feature is the historical essence of legal reasonableness: the original use of the “reasonable person” and the “man on the Clapham omnibus” aimed to reflect both statistical and prescriptive considerations. Empirically, reasonableness is a hybrid judgment. And normatively, reasonableness should be applied as a hybrid standard. (shrink)

One popular conception of natural theology holds that certain purely rational arguments are insulated from empirical inquiry and independently establish conclusions that provide evidence, justification, or proof of God’s existence. Yet, some raise suspicions that philosophers and theologians’ personal religious beliefs inappropriately affect these kinds of arguments. I present an experimental test of whether philosophers and theologians’ argument analysis is influenced by religious commitments. The empirical findings suggest religious belief affects philosophical analysis and offer a challenge to theists and atheists, (...) alike: reevaluate the scope of natural theology’s conclusions or acknowledge and begin to address the influence of religious belief. (shrink)

: Method in Catholic bioethics is distinguished by a specific philosophical and theological anthropology. Human beings are not to be considered simply as selves, but as selves in relation to God and each other. This essay reflects on that claim by reviewing four areas of concern from Catholic social teaching: common good, human dignity, option for the poor, and stewardship.

Rule-Consequentialism faces “the problem of partial acceptance”: How should the ideal code be selected given the possibility that its rules may not be universally accepted? A new contender, “Calculated Rates” Rule-Consequentialism claims to solve this problem. However, I argue that Calculated Rates merely relocates the partial acceptance question. Nevertheless, there is a significant lesson from this failure of Calculated Rates. Rule-Consequentialism’s problem of partial acceptance is more helpfully understood as an instance of the broader problem of selecting the ideal code (...) given various assumptions—assumptions about who will accept and comply with the rules, but also about how the rules will be taught and enforced, and how similar the future will be. Previous rich discussions about partial acceptance provide a taxonomy and groundwork for formulating the best version of Rule-Consequentialism. (shrink)

This brief essay describes the significance of Hillary Putnam's "Collapse of the Fact/Value Dichotomy" for Catholic thinkers who are inspired by Thomas Aquinas.

Statistical evidence is crucial throughout disparate impact’s three-stage analysis: during (1) the plaintiff’s prima facie demonstration of a policy’s disparate impact; (2) the defendant’s job-related business necessity defense of the discriminatory policy; and (3) the plaintiff’s demonstration of an alternative policy without the same discriminatory impact. The circuit courts are split on a vital question about the “practical significance” of statistics at Stage 1: Are “small” impacts legally insignificant? For example, is an employment policy that causes a one percent disparate (...) impact an appropriate policy for redress through disparate impact litigation? This circuit split calls for a comprehensive analysis of practical significance testing across disparate impact’s stages. Importantly, courts and commentators use “practical significance” ambiguously between two aspects of practical significance: the magnitude of an effect and confidence in statistical evidence. For example, at Stage 1 courts might ask whether statistical evidence supports a disparate impact (a confidence inquiry) and whether such an impact is large enough to be legally relevant (a magnitude inquiry). Disparate impact’s texts, purposes, and controlling interpretations are consistent with confidence inquires at all three stages, but not magnitude inquiries. Specifically, magnitude inquiries are inappropriate at Stages 1 and 3—there is no discriminatory impact or reduction too small or subtle for the purposes of the disparate impact analysis. Magnitude inquiries are appropriate at Stage 2, when an employer defends a discriminatory policy on the basis of its job-related business necessity. (shrink)

This paper reviews the origins of organisational economics and critically examines its influence on business-school scholarship and pedagogy in the eighties and nineties and argues three points. First, it is useful to analyse the infiltration of economic ideas about internal organisation of firms into organisational science within the context of the methodology of scientific research programmes. Second, the adoption by management theorists of organisational economics as part of a new science of organisations represented a significant change in research style within (...) business schools and may have contributed to practices that came under heavy criticism in the last decade. Third, the influence of economic ideas on management science represented not only an infusion of methods and models, but an infusion of ideology as well, raising important philosophical questions concerning the development of management science. (shrink)

This article considers the experiences of health consumers who have undergone testing for human immunodeficiency virus antibodies, T cells, and viral load. These HIV-related tests are deployed for the purposes of making definitive diagnoses; yet some test consumers experience ambiguous outcomes. Drawing on an analysis of differing end-user experiences of these tests, where consumers' knowledge reflected the multiplicity and heterogeneity in test design, the author explores how these experiences reflect particular knowledges about these tests. The article contributes to efforts analyzing (...) how health consumers are active end users co-constructing the social meaning of technologies in mutual relationship with other users. The author discusses how this new knowledge can be used to delineate a greater role for consumer evaluation of medical testing within a broader understanding of test design and performance. Relevant links are made to issues such as genetic testing and assessing claims about the efficacy of medical tests. (shrink)

A growing body of research has examined how people judge the persistence of identity over time—that is, how they decide that a particular individual is the same entity from one time to the next. While a great deal of progress has been made in understanding the types of features that people typically consider when making such judgments, to date, existing work has not explored how these judgments may be shaped by normative considerations. The present studies demonstrate that normative beliefs do (...) appear to play an important role in people's beliefs about persistence. Specifically, people are more likely to judge that the identity of a given entity remains the same when its features improve than when its features deteriorate. Study 1 provides a basic demonstration of this effect. Study 2 shows that this effect is moderated by individual differences in normative beliefs. Study 3 examines the underlying mechanism, which is the belief that, in general, various entities are essentially good. Study 4 directly manipulates beliefs about essence to show that the positivity bias regarding essences is causally responsible for the effect. (shrink)

Despite pervasive variation in the content of laws, legal theorists and anthropologists have argued that laws share certain abstract features and even speculated that law may be a human universal. In the present report, we evaluate this thesis through an experiment administered in 11 different countries. Are there cross‐cultural principles of law? In a between‐subjects design, participants (N = 3,054) were asked whether there could be laws that violate certain procedural principles (e.g., laws applied retrospectively or unintelligible laws), and also (...) whether there are any such laws. Confirming our preregistered prediction, people reported that such laws cannot exist, but also (paradoxically) that there are such laws. These results document cross‐culturally and –linguistically robust beliefs about the concept of law which defy people's grasp of how legal systems function in practice. (shrink)

A cross-cultural survey experiment revealed a dominant tendency to rely on a rule’s letter over its spirit when deciding which behaviors violate the rule. This tendency varied markedly across (k = 15) countries, owing to variation in the impact of moral appraisals on judgments of rule violation. Compared with laypeople, legal experts were more inclined to disregard their moral evaluations of the acts altogether and consequently exhibited stronger textualist tendencies. Finally, we evaluated a plausible mechanism for the emergence of textualism: (...) in a two-player coordination game, incentives to coordinate in the absence of communication reinforced participants’ adherence to rules’ literal meaning. Together, these studies (total n = 5,794) help clarify the origins and allure of textualism, especially in the law. Within heterogeneous communities in which members diverge in their moral appraisals involving a rule’s purpose, the rule’s literal meaning provides a clear focal point—an identifiable point of agreement enabling coordinated interpretation among citizens, lawmakers, and judges. (shrink)

Sustainable products are engineered to reduce environmental, ecological, and human costs of consumption. Not all consumers value sustainable products, however, and this poses negative societal implications. Using self-expansion theory as a guide, we explore how an individual’s general sense of belonging—or the perception that one is accepted and valued by others in the broader social world—alters their responses to sustainable products. Five experimental studies and a field study demonstrate that individuals lower in belonging respond less favorably to sustainable products in (...) terms of evaluations and willingness to pay than individuals higher in belonging. Process evidence shows that the extent to which individuals low in belonging perceive that collective, sustainable choices will impact them personally drives this result and that belonging does not impact responses to conventional (i.e., non-sustainable) products. However, perceiving a shared human experience—or that individuals share some important, basic similarities with all people—attenuates the negative effect of low belonging on responses to sustainable products for consumers both low and high in belonging. This research has significant implications for businesses and society given the growing sense of disconnect in modern society. (shrink)